Vacuum Therapy and Cleansing Dressing for Wounds

ABSTRACT

A wound dressing member is provided for use in a vacuum bandage connected to a vacuum source. The wound dressing member is also provided for use with a wound having a wound surface. The wound dressing member includes a wound facing surface adapted to be in contact with and generally conform to the wound surface and a plurality of discrete holes formed in the wound facing surface. The member further includes a port configured to communicate with the vacuum source and with each hole formed in the wound facing surface. The wound dressing member further includes a stand-off having interconnected portions coupled to the wound facing surface and configured to provide a space between the wound facing surface and the wound surface.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of co-pending U.S. patent applicationSer. No. 11/051,283 filed Feb. 4, 2005, which is a continuation of U.S.patent application Ser. No. 10/144,504 filed May 13, 2002, now U.S. Pat.No. 6,855,135, which is a Continuation-in-Part of U.S. patentapplication Ser. No. 09/994,537 filed Nov. 27, 2001, now U.S. Pat. No.6,752,794, which is a Continuation-in-Part of U.S. patent applicationSer. No. 09/725,352 filed Nov. 29, 2000, now U.S. Pat. No. 6,685,681,all of which are herein incorporated by reference.

BACKGROUND AND SUMMARY OF THE INVENTION

The present invention relates to bandages for wounds, and moreparticularly to the provision of bandages for use with a vacuum source.

The prior art contemplates that chronic wounds may be treated byproviding a vacuum in the space above the wound to promote healing. Anumber of prior art references teach the value of the vacuum bandage orthe provision of the vacuum in the space above the surface of a chronicwound.

A vacuum bandage is a bandage having a cover which seals about the outerperimeter of the wound and under which a vacuum is established to act onthe wound surface. This vacuum applied to the wound surface causeshealing of chronic wounds. Typically, suction tubes are provided fordrawing away exudate from the wound, and this suction may be used tocreate the vacuum under the cover. If the cover is a flexible cover,which is typically more comfortable for the patient, some sort of porouspacking may be provided under the cover to provide the space in whichthe vacuum is formed. The following U.S. Patents establish the nature ofvacuum treatment bandages and devices: 6,095,992, 6,080,189, 6,071,304,5,645,081, 5,636,643, 5,358,494, 5,298,015, 4,969,880, 4,655,754,4,569,674, 4,382,441, and 4,112,947. All of such references areincorporated herein by reference for purposes of disclosing the natureof such vacuum treatment of wounds.

As shown, for example, in U.S. Pat. No. 5,645,081 (hereinafter the '081patent), a method of treating tissue damage is provided by applyingnegative pressure to a wound. The negative pressure is provided insufficient duration and magnitude to promote tissue migration in orderto facilitate the closure of the wound. FIG. 1 of the '081 patentdiscloses an open cell polyester foam section covering the wound, aflexible hollow tube inserted into the foam section at one end andattached to a vacuum pump at another end, an adhesive sheet overlyingthe foam section and tubing to adhere to the skin surrounding the woundin order to form a seal that allows the creation of a vacuum when thesuction pump is operating. The '081 patent further teaches use ofnegative pressure between about 0.1 and 0.99 atmospheres, and that thepressure can be substantially continuous, wherein the pressure isrelieved only to change the dressing on the wound. Alternatively, the'081 patent teaches use of a cyclic application of pressure inalternating periods of application and non-application. In a preferredembodiment, pressure is applied in 5 minute periods of application andnon-application.

Various other prior art references teach the value of the vacuum bandageor the provision of vacuum to the surface of a chronic wound. SeveralRussian language articles exist which establish the efficacy of vacuumtherapy discovered in the 1980's. Examples of such prior art articles,each of which discusses the use of application of vacuum to a wound topromote healing, are as follows: “Vacuum therapy in the treatment ofacute suppurative diseases of soft tissues and suppurative wounds”,Davydov, et al., Vestn, Khir., September 1988 (the September 1988article); “Pathenogenic mechanism of the effect of vacuum therapy on thecourse of the wound process”, Davydov, et al Khirurigiia, June 1990 (theJune 1990 article); and “Vacuum therapy in the treatment of suppurativelactation mastitis”, Davydov, et al. Vestn. Khir., November 1986 (theNovember 1986 article).

The Russian articles distinguish wound drainage from the use of vacuumtherapy for healing. The Russian authors report that vacuum therapyresulted in faster cleansing of the wound and more rapid detoxificationthan with the traditional incision-drainage method. The November 1986Russian article describes the vacuum therapy techniques as a reductionof 0.8-1 atmosphere for 20 minutes at the time of surgery, andsubsequent 1.5 to 3 hour treatments at a reduced pressure of 0.1 to 0.15from atmosphere, twice daily. These Russian articles teach the use ofnegative pressure to effect healing. The articles describe using severalsessions per day, each lasting up to one hour, with a vacuum of 76-114mmHg. The Russian articles teach using this vacuum method to decreasethe number of microbes in the wound. The June 1990 article teaches thatthis vacuum therapy provides a significant antibacterial effect. Thearticle describes the stepped up inflow of blood to the zone around thewound to lead to an increase in the number of leukocytes reaching thefocus of inflammation. Subsequent articles and patents further developthe benefits obtained with vacuum therapy. The prior art, therefore,teaches the benefit and value of a vacuum bandage.

According to the present disclosure, a thin, flexible member for use ina vacuum bandage is provided. The member includes a wound contactingsurface configured to be in contact with and conform to a wound surfaceof a wound. The member further includes a plurality of discrete holesformed in the wound contacting surface, a port which communicates withthe vacuum source, and communicating means between the holes and theport. The member is made from a generally non-compressible material.Further, the material is generally transparent and non-porous.

In some illustrative embodiments, the communicating means comprises aplurality of distinct passageways between each hole and the port. Themember includes a wound contacting layer having channels formed thereinand a cover coupled to the wound contacting layer. The cover cooperateswith the wound contacting layer, and the channels formed therein, todefine the passageways. The member further includes a boss positionednear the port of the cover to prevent an upper surface of the woundcontacting layer from sealing off the port of the cover when vacuum isapplied to the port.

In some illustrative embodiments, the wound contacting surface of themember includes spacers contacting the wound to define a suction spacebetween the member and the wound surface. The wound contacting surfacemay also be textured or roughened for contact with the wound surface.The unevenness of the textured or roughened surface providescommunication of the negative pressure across the wound surface.

In some embodiments, the spacers and suction space are defined by aplurality of channels formed in the wound contacting surface. Each ofthe channels formed in the wound contacting surface opens toward thewound surface and includes side edges contacting the wound.

In some embodiments of the invention, the dressing member has such aplurality of channels formed in patterns on both of the wound contactingsurface and the opposite surface and the plurality of holes providecommunication between the channels on both surfaces. In someembodiments, the channel patterns on both surfaces are congruent orsuperimposed with both patterns radiating outwardly from the port andwith the holes spaced radially along the channels.

In some embodiments, the dressing member is made from a material whichis to be trimmed conformingly to fit the wound. In some embodiments, thedressing member is relatively transparent such that the condition of thewound surface can be observed through the wound member.

There is provided, therefore, a dressing for a wound, the dressingcomprising a relatively thin flexible member which can be trimmedconformingly to fit the wound surface. A suction and irrigation port isassociated with the dressing member, and a plurality of channels orpassageways is formed in the member leading away from the port toprovide communication between the port and areas of the wound surface.The dressing member is provided with a plurality of through holes incommunication with the channels. A packing may be placed over theflexible member and a sealing film may be placed over the packing toseal around the perimeter of the wound to provide an enclosed spaceabove the member in which a vacuum is formed by suction on the port. Itwill be appreciated, however, that some caregivers may choose to leavepacking out of the bandage and have the sealing film placed directlyover the flexible member. It has been found that some bandages functionquite well without packing. Also, visual observation is improved withoutthe packing. Irrigation fluid may be introduced to the port to impingeupon the wound surface and this fluid and wound exudate is removed fromthe space between the wound and the bandage member by suction applied tothe port. It will be appreciated that the vacuum therapy and theirrigation therapy may take place without removal of the bandage. Theillustrative member with the downwardly opening channels or spacers onthe wound contacting surfaces provides a suction space which willuniformly apply the vacuum and the irrigation to the surface of thewound bed.

The covered channels on the opposite surface and the holes through themember further contribute to the ability to uniformly apply the vacuumtherapy and irrigation fluid to the wound surface. A relatively largeportion of the wound surface will be exposed to the vacuum therapy andirrigation using the illustrative bandage member. A large number ofredundant passageways are provided for communicating from the accessport directly to the wound surface. While some of the passageways maybecome blocked by exudate particles from the wound surface, otherpassageways will remain open for suction and irrigation.

The illustrative bandage, therefore, provides a relatively thin,flexible, comfortable bandage member which can be trimmed generallyconformingly to fit into a wound bed and apply vacuum therapy andirrigation uniformly to the wound surface. The illustrative coveredchannel passageways on the opposite (upper or outer) surface provide amultitude of clearly defined passageways leading from the access port tothe through holes leading directly into the suction space under themember.

In further embodiments, the member includes a connecter coupled to thecover for communication with the port of the cover. The connecter isconfigured for communication with the vacuum source and defines aright-angled passageway to provide a horizontal tube attachment.

In yet another embodiment, the member further includes an outer adhesiveperimeter. This perimeter is configured to seal about the wound to apatient's healthy skin surrounding the wound. In another embodiment, themember further includes a wire form to permit a user or caregiver tomold or shape the member to fit the particular shape of a wound. In oneembodiment, the wire form is molded into the cover and in anotherembodiment the wire form is molded into the wound contacting layer.

In still another embodiment, the member further includes a plurality ofirrigation passageways configured for communication with an irrigationsource and with the wound surface. The irrigation passageways aredistinct from the passageways described above which are configured forcommunication with the vacuum source. The member further includes anirrigation port in communication with the irrigation passageways andconfigured for communication with the irrigation source. An irrigationlayer is provided and includes channels formed therein which define theirrigation passageways.

A wound bandage for use on a chronic wound located on a patient's heelis also disclosed. In this embodiment, the member is saddle-shaped andincludes an upper portion, a lower portion, and a neck portion coupledto and positioned between the upper portion and the lower portion. Thesaddle-shaped member is foldable into a configuration that cups thepatient's heel. An embodiment having a member with a generally“V-shaped” cross-section is provided for use with sternal or abdominalwounds. The V-shaped member includes a right wing and a left wingcoupled to the right wing. Further, the V-shaped member includes acentral passageway in communication with the port of the cover and aplurality of lateral passageways in communication with the centralpassageway.

Another alternative member is disclosed for use with tunneled wounds.This member includes a truncated cone-shaped portion, a tube-shapedportion coupled to the cone-shaped portion, and a dome-shaped portioncoupled to the tube-shaped portion. The port is positioned in thecone-shaped portion. Yet another member is disclosed which isdome-shaped and has a convex wound contacting surface.

A method of forming a member of a wound bandage is further provided inaccordance with the present disclosure. The method includes the steps ofmolding a cover from a semi-cured silicone and the step of heat-sealingthe cover to a wound contacting layer. In illustrative embodiments, themethod further includes providing a connecter and heat sealing theconnecter to the cover. In further embodiments, the method includesmolding the connecter and the wound contacting layer from fully-curedsilicone.

Additionally, a method of treating an open wound having a wound surfaceis provided in accordance with the present disclosure. The methodincludes the steps of providing a flexible member fabricated fromnon-porous material to have a wound contacting surface with holes in thesurface, a port configured to communicate with a vacuum source, andpassageways providing communication between the holes and the port. Themethod further includes placing the member into contact with the woundto functionally and physically interface with the wound surface andconnecting the port to a vacuum source to provide suction at each of theholes. In illustrative embodiments, the method further includes the stepof covering the wound and the member adjacent the wound to provide aspace in which a vacuum is established by the vacuum source. In otherembodiments, the method includes the step of irrigating the woundsurface by connecting the port to a source of irrigation fluid expelledthrough the holes onto the wound surface.

Another alternative member is provided including a single stand-offcoupled to the wound contacting or wound facing surface of the member.The stand-off includes a plurality of interconnected portions.Illustratively, the stand-off forms a spider-web-like design having acircle portion and a plurality of radial arms extending outwardly fromthe circle portion. Further illustratively, the stand-off includes anarc portion spaced-apart from and concentric with the circle portion.The radial arms extend through the arc portion. The cross-section of thestand-off is in the shape of a semi-circle having a radius ofapproximately 1.56 mm. The stand-off defines encompassed regions of thewound facing surface of the member.

Features of the invention will become apparent to those skilled in theart upon consideration of the following detailed description ofpreferred embodiments exemplifying the best mode of carrying out theinvention as presently perceived.

BRIEF DESCRIPTION OF THE DRAWINGS

The detailed description particularly refers to the accompanying figuresin which:

FIG. 1 is a part perspective, part diagrammatic view of a wound carebandage showing the wound care bandage located on the leg of a patientand coupled to both a vacuum and an irrigation source through the use ofa switch valve;

FIG. 2 is a top view of a member of the wound care bandage showing themember including a vacuum/irrigation port, a plurality of channelsradiating outwardly from the port, and through holes which extendthrough the member;

FIG. 3 is an exploded view of one embodiment of the wound care bandageshowing the member having a wound contacting surface and an oppositesurface, a cover adjacent the opposite surface, tubing which connects tothe port of the member at one end and to the vacuum and irrigationsources at another end, packing to be placed on top of the tubing andmember, and a sealing film which closes and seals the bandage to allow avacuum environment to be created;

FIG. 4 is a top view of a portion of the bandage showing the cover withportions broken away and showing the member and the channels of themember enclosed by the cover in order to form passageways extending awayfrom the port;

FIG. 5 is a sectional view taken along line 5-5 of FIG. 4 showing thetube which may be sealed to the port, showing a shallow cone of theport, and also showing the channels of the opposite surface and channelsof the wound contacting surface and the holes which communicate betweenthe channels;

FIG. 6 is a top view of the portion of the member and cover shown inFIGS. 4 and 5 after having been trimmed to fit the particular wound ofthe patient;

FIG. 7 is a sectional view of the bandage within the wound of thepatient showing the wound surface, the wound contacting surface of themember adjacent the wound surface, the cover adjacent the oppositesurface of the member, the tubing coupled to the port of the member,packing, and the outer film coupled to the patient's healthy skin toseal the environment;

FIG. 8 is another embodiment showing an alternate wound contactingsurface of the member including spacers for contacting the wound surfaceto form an open space between the member and the wound surface;

FIG. 9 is a sectional view taken along line 9-9 of FIG. 8 showing onespacer and a through hole of the alternate member;

FIG. 10 is another embodiment showing an another wound contactingsurface of the member including spacers or oblong ridges provided toform an open space between the member and the wound surface when themember is placed in the wound;

FIG. 11 is a sectional view taken along line 11-11 of FIG. 10 showingone oblong ridge and through hole of the alternate member;

FIG. 12 is another embodiment showing a wound care bandage having twoports;

FIG. 13 is another embodiment showing an alternate opposite surface ofthe member having ridges radially spaced around the port to provide ameans of flow for exudate being vacuumed from the wound and/or forliquid being dispensed to the wound through the port;

FIG. 14 is a sectional view taken along line 14-14 of FIG. 13.

FIG. 15 is yet another embodiment showing a bandage having a pluralityof ports each coupled to a vacuum/irrigation tube to provide an evenlydistributed suction force across the member;

FIG. 16 is another embodiment showing a member of the bandage having acentral aperture at the port of the member and channels extendingradially outwardly from the central aperture;

FIG. 17. is an exploded perspective view of another wound care bandagesimilar to the wound care bandage of FIG. 1 showing the bandagepositioned above a wound bed and including a wound contacting layer anda cover of the bandage which cooperate to form a wound dressing memberfor placement within the wound bed, and also showing sealing film tocover the member and seal about the wound;

FIG. 18 is a sectional view of the member of FIG. 17 showing thenon-porous nature of the member and also showing distinct passagewaysand through holes of the member;

FIG. 19 is a sectional view similar to FIG. 18 showing roundedprotrusions or bosses of the wound contacting layer adjacent to thecover and positioned about a port of the cover;

FIG. 20 is a bottom perspective view of the member showing a smoothwound contacting surface of the member and also showing the transparentnature of the member;

FIG. 21 is a bottom view of a portion of a member having a rough ortextured wound contacting surface;

FIG. 22 is a sectional view taken along line 22-22 of FIG. 21 showingthe irregular texturing of the wound contacting surface of the member;

FIG. 23 is a top view of a member showing the member being saddle-shapedfor use on a heel, as shown in FIG. 25, for example, and also showing acentrally located connecter coupled to the cover and in communicationwith a central port of the cover and channels of the wound contactinglayer radiating outwardly from the port;

FIG. 24 is a top view of another member, similar to the embodiment ofFIG. 23, showing the member being saddle-shaped, a port positioned on anupper portion of the member, and lateral passageways of the memberextending outwardly and downwardly from a vertical central passageway ofthe member;

FIG. 25 is a perspective view of the member shown in FIG. 24 positionedaround the heel of a patient's foot;

FIG. 26 is a perspective view of another embodiment of the membershowing the member having a truncated cone-shaped portion coupled to atube-shaped portion for use with tunneled wounds, as shown in FIG. 27;

FIG. 27 is a sectional view of the member shown in FIG. 26 showing themember positioned within the tunneled wound of a patient;

FIG. 28 is a top view of a “V-shaped” member for use with sternal orabdominal wounds, for example;

FIG. 29 is a perspective view of the V-shaped member of FIG. 28 showingthe member on the sternal wound of a patient;

FIG. 30 is a sectional view taken along line 30-30 of FIG. 29 showingthe V-shape of the member and also showing the wound contacting surfaceof the member adjacent the sternal wound surface;

FIG. 31 is a perspective view of yet another embodiment of the member ofthe present invention showing the member being dome-shaped and having aconvex wound contacting surface;

FIG. 32 is a perspective view of another embodiment of the bandageshowing a vertical tube attachment at the port of the member;

FIG. 33 is an exploded perspective view of another embodiment of themember showing a cover of the member having channels formed therein andalso showing a wound contacting layer of the member having a smoothsurface and thru holes for communication with the channels of the cover;

FIG. 34 is a sectional view of a portion of the member of FIG. 33;

FIG. 35 is an exploded perspective view of another member showing themember including a cover, a wound contacting irrigation layer, and anintermediate layer positioned between the cover and the irrigationlayer;

FIG. 36 is a sectional view of the member of FIG. 35 showing theirrigation layer in communication with an irrigation source (illustrateddiagrammatically) and showing the cover in communication with a vacuumsource (illustrated diagrammatically) to provide the member with thecapability to simultaneously apply vacuum and irrigate the wound;

FIG. 37 is a bottom view of a cover showing a filament or wire formmolded into the cover to allow the member to retain a desired shape whenshaped or formed by a user or caregiver to fit a particular wound, forexample;

FIG. 38 is a sectional view of a member including the cover and wireform shown in FIG. 37;

FIG. 39 is a bottom view of another member showing the wound contactinglayer having an adhesive outer perimeter for sealing about the wound inorder to provide a self-sealing member, as shown in FIG. 40;

FIG. 40 is a sectional view of the member of FIG. 39 showing the outeradhesive perimeter of the wound contacting layer coupled to thepatient's healthy skin surrounding the wound in order to seal the memberabout the wound without the use of the sealing film shown in FIG. 17;

FIG. 41 is a top view of the member of the present invention showing thecover of the member including scale markings to provide a caregiver witha reference point for trimming the member to fit the particular wound ofthe patient;

FIG. 42 is a perspective view of another member of the present inventionshowing a wound contacting layer, a cover, and a connector coupled tothe cover of the member and also showing the connector having a single,angled passageway;

FIG. 43 is a bottom perspective view of the wound contacting layer ofthe member of FIG. 42 showing a single stand-off coupled to the woundcontacting surface of the layer and generally forming a spider-web-likepattern having radially extending portions and concentric circularportions; and

FIG. 44 is a sectional view showing the angled connector of the memberof FIGS. 42 and 43 coupled to a multi-lumen tube by a barbed tubecoupler.

DETAILED DESCRIPTION OF THE DRAWINGS

A wound care bandage 10 is provided for use with a vacuum and irrigationsource 12, 14, respectively, as shown in FIG. 1. An illustrative vacuumand irrigation source 12, 14 is disclosed in application Ser. No.09/725,666 filed on Nov. 29, 2000 and application Ser. No. 09/369,113filed Aug. 5, 1999. These pending applications, which are each owned bythe assignee of this present application, are specifically incorporatedherein by reference.

Bandage 10 promotes the healing of a large wound 16 (shown in FIGS. 3and 7) by providing vacuum therapy to the wound 16 to promote blood flowand remove exudate from a wound surface 18 of the wound 16 and byproviding for irrigation of the wound 16 with fluids such as saline, forexample.

As shown in FIG. 3, wound care bandage 10 comprises a thin, flexiblewound dressing member 20, shown in FIG. 2. Member 20 is made of amedical grade silicone or other type of elastomer which is pliable. Twocompanies, for example, which manufacture such medical grade siliconeare GE Silicones and NuSil Technology. It is within the scope of thisdisclosure, however, to include a wound dressing member made of any typeof thin, flexible material that is non-porous and non-foam-like. Thisthin, flexible material is also generally non-absorptive. For example,materials such as polyvinylchloride (PVC), PVC free of diethylhexylphthalate (DEHP-free PVC), polyurethane, or polyethylene may be used inthe manufacture of member 20.

Further, member 20 may be molded to include anti-microbial constituents.For example, it is within the scope of this disclosure to impregnatemember 20 with silver ions which are known anti-microbials. Thefollowing PCT publications illustrate the use of anti-microbials invarious products and are incorporated herein by reference:“Antimicrobial Plastic Closures for Drinking Containers”, WO 00/26100;“Antimicrobial Contact Lens Case”, WO 00/038552; “Antimicrobial Fabricand Medical Graft of the Fabric”, WO 00/32247; “Antimicrobial SuturingRing for Heart Valve”, WO 00/30567.

Member 20 is also made of a generally non-adhesive material. Therefore,wound contacting layer 22, which lies adjacent to the wound surface 18,does not adhere to the wound surface 18. Further, member 20 is solid innature and generally non-compressible. For example, when a negativepressure is applied to member 20, a thickness, t, of member 20, as shownin FIG. 3, remains relatively constant.

As shown in FIG. 2, wound dressing member 20 is illustrativelyrectangular in shape. However, it is within the scope of the thisdisclosure for member 20 to be any suitable shape, some illustrativeexamples of which are described below in FIGS. 23-31. Further, member 20may be cut to fit any size wound 16, as shown in FIGS. 4 and 6. Member20 is illustratively molded with a thickness of

0.080 inches (2.032 mm). Illustratively, member 20 is made from asilicone of a Durometer 10A which is flexible. It will be appreciatedthat the channels or passageways formed in the member, as describedbelow, will further contribute to its flexibility.

Member 20 includes a wound contacting surface 22 and an opposite surface24. Wound contacting surface 22 or portions thereof contact the woundsurface 18 as shown in FIG. 7. Looking to FIG. 2, it can be seen thatopposite surface 24 includes a central area defining a vacuum/irrigationport 26. A plurality of channels 28 are formed in opposite surface 24and extend radially away from central area or port 26. Illustratively,each channel 28 is 0.030 inches (0.762 mm) wide and 0.030 inches (0.762mm) deep. It is within the scope of this disclosure, however, to includechannels 28 of member 20 having various widths and depths suitable forthe present application. Port 26, as shown in FIG. 5, includes a shallowcone 64 in order to induce fluids dispensed through a vacuum/irrigationtube 13 from the vacuum and irrigation sources 12, 14 to flow evenlyinto channels 28. In an alternate embodiment shown in FIG. 16, analternate port 86 includes an aperture 88 formed through member 20. Inthe FIG. 16 embodiment, the port communicates directly with thesuction/irrigation space between the member 20 and the surface of thewound.

Vacuum/irrigation tube 13 is in communication with central area or port26 of member 20 via a port 51 of a cover 52 (described below) of thebandage 10 coupled to the port. The tube 13 may be molded as part of themember 20 or attached to the member by welding, adhesion or other knowntechniques. The tube is preferably made of silicone, however, it iswithin the scope of this disclosure to include a vacuum/irrigation tubemade of other medically suited materials. Opposite surface 24 furtherincludes channels 30 which are concentric with port 26, as shown in FIG.2. Concentric channels 30 have the same width and depth as that ofchannels 28 described above.

Wound contacting surface 22 includes a plurality of channels 32 whichradiate outwardly from the center of member 20 similar to channels 28 ofopposite surface 24. Similarly, wound contacting surface 22 alsoincludes a plurality of channels 34 concentric with the center of member20. Each channel 32, 34 of wound contacting surface 22 opens toward thewound surface 18 and includes outer edges 42 which contact the woundsurface 18 or which act as spacers to provide space between the member20 and the wound surface. Illustratively, the channels 32,34 of woundcontacting surface 22 have the same dimensions as the channels 28, 30 ofopposite surface 24. In other words, illustratively channels 32, 34 ofwound contacting surface 22 are 0.030 inches (0.762 mm) deep and 0.030inches (0.762 mm) wide. However, it is within the scope of thisdisclosure to include channels 32, 34 of surface 22 having other widthsand depths.

Through holes 36 are provided in member 20 for communication between thechannels 28, 30 of the opposite surface 24 with the channels 32, 34 ofthe wound contacting surface 22. As shown in FIG. 2, holes 36 areillustratively positioned to lie within concentric channels 30, 34 ofeach respective surface 22, 24 of member 20. Holes 36 are illustratively0.030 inches (0.762 mm) in diameter and are illustratively spacedapproximately 0.500 inches (12.700 mm) apart along channels 28, 30, and32, 34 of each respective surface 22, 24. Member 20 is provided insmall, medium, and large sizes. The small sized member has a length of3.00 inches (76.20 mm) and a width of 4.00 inches (101.60 mm); themedium sized member has a length of 4.00 inches (101.60 mm) and a widthof 6.00 inches (152.40 mm); the large sized member has a length of 6.00inches (152.40 mm) and a width of 10.00 inches (254.00 mm). The holes ofthe small and medium sized members 20 are 0.030 inches (0.762 mm) indiameter. The large sized member, however, includes some holes having adiameter of 0.030 inches (0.762 mm) and other holes having a diameter of0.040 inches (1.016 mm). It is, however, within the scope of thedisclosure to include members of other suitable shapes and sizesincluding holes having other suitable size diameters and other spacingas well.

Channels 32, 34 of wound contacting surface 22 provide open spaces 40between the wound surface 18 and member 20, as shown in FIG. 7. Openspaces 40 are defined by each channel 32, 34 of wound contacting surface22, each outer edge 42 of channels 32,34, and wound surface 18. Eachthrough hole 36 of member 20 opens into the open spaces 40 formed bychannels 32, 34. Open spaces 40 allow vacuum source 12 to establish agenerally uniformly distributed vacuum therapy to draw exudate from thewound 16 into the channels 32, 34 of wound contacting surface 22.

It is within the scope of this disclosure to provide spacers 46, forexample, shown in FIGS. 8 and 9. Spacers 46 protrude outwardly fromwound contacting surface 22 to contact wound surface 18. Open spaces 40are provided between spacers 46. As shown in FIG. 9, each spacer 46 hasan illustrative depth of approximately 0.030 inches (0.762 mm). Howeverit is within the scope of this disclosure to include spacers havingother suitable dimensions which provide open spaces 40. As with member20 including channels 32, 34 on wound contacting surface 22, holes 36 ofmember 20 including spacers 46 are positioned to open into the openspaces 40.

Further, it is within the scope of this disclosure to include member 20having other types of spacers on wound contacting surface 22 whichcreate open spaces 40 when wound contacting surface 22 is adjacent thewound surface 18. In another embodiment, as shown in FIGS. 10 and 11,oblong ridges 50 are provided on wound contacting surface 22. Ridges 50are similar in shape and function to spacers 46. Ridges 50 protrude awayfrom member 20 and contact wound surface 18 when member 20 is place onwound surface 18 to provide open spaces 40 between wound surface 18 andmember 20 to establish a generally uniform vacuum across the woundsurface 18. As shown in FIG. 11, each ridge 50 illustratively has apreferred depth of 0.030 inches (0.762 mm), however, a ridge havingother suitable dimensions is within the scope of this disclosure. Asillustrated by channels 32,34 of wound contacting surface 22, spacers46, or ridges 50, it is within this disclosure to include otherstructures which acts as spacers to create open spaces 40 between thewound surface 18 and member 20 when member 20 is placed on the woundsurface 18 to distribute suction and irrigation generally uniformlythroughout the wound 16. For example, the wound contacting surface maybetextured or roughened as illustrated by irregular nubs 74 in FIGS. 21and 22. This textured surface is described in more detail below withrespect to a bandage 11 shown in FIG. 17.

As mentioned above, bandage 10 further comprises cover 52 for coveringand coupling to opposite surface 24 of member 20. Port 51 of cover 52communicates with central area or port 26 of member 20 and channels 28of member 20. Cover 52 is provided to cover channels 28, 30 of oppositesurface 24. Cover 52 and channels 28 of opposite surface 24 cooperate toform passageways 56, as shown in FIG. 7, extending away from port 26.Passageways 56 are also formed by the cooperation of concentric channels30 of opposite surface 24 and cover 52. Cover 52 is adhered to member 20through the use of an adhesive or other suitable means such as heatsealing, for example, which is described in more detail below. It willbe appreciated that the covered channels 28, 30 provide an ideal way tofabricate a multitude of passageways 56 communicating with the woundsurface. In an alternate embodiment, passageways 56 are formed bycooperation of ridges 54 on opposite surface 24 of member 20, ratherthan channels 30, and cover 52, as shown in FIGS. 13 and 14, forexample. It is within the scope of this disclosure to include a bandage10 forming other passageways 56 extending away from port 26. Holes 36 ofmember 20 having ridges 54 are located within passageways 56 of bandage10 similar to holes 36 of member 20 having radial channels 28 andconcentric channels 30.

It will be appreciated that the illustrative cover 52 may be providedwith scale marking for gauging the wound size or healing progress.Circular markings may be added at 0.5 cm or 1.0 cm intervals, forexample, to provide convenient measuring of the wound and healingprogress.

As shown in FIGS. 3 and 7, bandage 10 further includes gauze or othersuitable packing 58 which lies on top of cover 52 and is provided tofill the wound 16 up to the surface of the patient's healthy skin 60. Asnoted above, such packing 58 may be optional with the caregiver. Asealing film 62 of bandage 10 is placed over packing 58. Film 62 isprovided to cover the entire wound 16 and to extend across and attacharound tube 13 to the patient's healthy skin 60, as shown in FIGS. 1 and7. Preferably, film 62 is an occlusive or semi-occlusive material whichallows water vapor to permeate through. Because of this characteristic,the film 62 is referred to as Moisture Vapor Transmission Rate film orMVTR film. The products Tegaderm™, made by 3M, and OpSite™ made by Smithand Nephew can be used for film 62, for example. The product OpSite™ isa semi-permeable film. Film 62 is approximately 0.003 inches (0.076 mm)thick, however, it is within the scope of this disclosure to include anyocclusive or semi-occlusive film 62 having other thickness. Film 62 isprovided to create a sealed environment below the film 62 and around thewound 16 in which a vacuum or negative pressure can be maintained asprovided by vacuum source 12.

As shown in FIG. 7, vacuum/irrigation tube 13 or an extension added tothe tube 13 extends over the edge of member 20 and cover 52 and out fromunder the edge of the sealing film 62. In use, irrigation source 14delivers liquid through tube 13 and port 51 of cover 52 to port 26 andonto the top of a shallow cone 64 of member 20 which extends upwardly asshown in FIGS. 5 and 7. Cone 64 acts to spread the liquid out throughthe passageways 56 formed by the cooperation of channels 28, 30 (orridges 54) and cover 52. The fluid moves radially out throughpassageways 56 to holes 36. The fluid then moved down through holes 36to open spaces 40 to impinge on wound surface 18.

A switch valve 66 is illustratively provided, as shown in FIG. 1, toallow a user to switch between the use of the vacuum source 12 and theirrigation source 14. It will be appreciated that mechanism other thanthe switch valve 66 may be used selectively to couple the vacuum sourceor the irrigation source to the bandage. Simple tube clamps, forexample, may be used selectively to open and close the tube set providedwith the bandage 10. When valve 66 is switched to operate the vacuumsource 12, the vacuum suction draws exudate into the open spaces 40 andup through the holes 36. The exudate is then drawn radially inwardlythrough passageways 56 toward port 26 and finally through tube 13.

Although illustrative bandage 10 includes one central port 51 of cover52 and central area or port 26 of member 20, it is within the scope ofthis disclosure to include multiple ports 70, as shown in FIGS. 12 and15, for example. Bandage 10 may make use of two ports 70 located atopposite ends of member 20, as shown in FIG. 12. Alternately, as shownin FIG. 15, bandage 10 may make use of a plurality of ports 70 spacedthroughout member 20. It is contemplated that, in some embodimentshaving two ports, one port may be used for suction or vacuum therapy andthe other port may be used for irrigation therapy.

It is contemplated that irrigation source 14 may be operated to provideirrigation fluid at various selected pressures. It is also contemplatedthat the bandage 10 and dressing member 20 may be provided in varioussizes and shapes, some examples of which are shown in FIGS. 23-31 andare discussed below. The dressing member 20 may be reused with a singlepatient. It is also contemplated that the dressing 10 may be used withmanual irrigation (where a nurse uses the syringe manually) as well asthe powered syringe 14.

Referring now to FIGS. 17-22, there is shown another exemplaryembodiment of a wound care bandage 11. Bandage 11 is somewhat similar tobandage 10. As such, the same reference numerals have been used todesignate similar components to those components previously discussed inregard to FIGS. 1-7, and additional discussion thereof is not warranted.One difference between bandage 10 and bandage 11 is that a wounddressing member 19 of FIGS. 17-22 is defined as including thecombination of a wound contacting layer 80, similar to member 20 ofFIGS. 1-7, cover 52 coupled to layer 80, and a connecter 23 coupled tocover 52 for communication with vacuum source 12 and/or irrigationsource 14. It is also within the scope of this disclosure for connecter23 to be integrally coupled to cover 52.

Similar to member 20, member 19 is thin and flexible. Layer 80, cover52, and connecter 23 are each made of a medical grade silicone or othertype of pliable elastomer as described above with respect to member 20.Member 19 is similarly non-porous, non-foam-like, and generallynon-absorptive. Materials such as PVC, DEHP-free PVC, polyurethane, orpolyethylene may similarly be used in the manufacture of member 19.Further, layer 80, cover 52, and connecter 23 of member 19 may each bemolded to include anti-microbial constituents similar to member 20.

Also similar to member 20, member 19 is made of a generally non-adhesivematerial to prevent wound contacting layer 80, which lies adjacent tothe wound surface 18, from adhering to the wound surface 18. Further,member 19 is similarly solid in nature and generally non-compressible.For example, when a negative pressure is applied to member 19, athickness t′, of member 19, as shown in FIGS. 18 and 19, remainsrelatively constant. Thickness, t′, represents solid areas of member 19where a channel or passageway is not present. Member 19 is generallypliable and .flexible, but is not generally compressible. Further, asshown in FIG. 20, member 19 (like member 20) is transparent to enable acaregiver to be able to see the wound 16 through member 19 when member19 is placed adjacent to wound surface 18. This transparency allows thecaregiver to view the progress of the healing of the wound 16.

Layer 80 includes a wound contacting surface 84 and an upper or oppositesurface 85. Wound contacting surface 84, or portions thereof, contactsand generally conforms to the wound surface 18. Opposite surface 85includes a central area 87 and the same plurality of channels 28, shownpreviously in FIGS. 2-4 with respect to member 20. Channels 28 extendradially away from central area 87. Central area 87 is similar tocentral area or port 26 of a member 20 in that central area 87communicates with port 51 of cover 52. However, central area 87 isrecessed relative to the portions of upper surface 84 between channels28, as shown in FIGS. 18 and 19. As shown in FIGS. 17 and 20, channels28 are open at the sides and ends of member 19, similar to channels 28of member 20. Opposite surface 85 further includes concentric channels30, shown in FIGS. 17, 20 and 21. As shown in FIG. 17, central area 87of layer 80 is provided to communicate with the vacuum source 12 andirrigation source 14 through cover 52, as will be described below.

A plurality of radially extending protrusions or bosses 90 arepositioned around central area 87. Bosses 90 are positioned betweencentral area 87 and channels 28, 30, as shown in FIG. 17. Bosses 90prevent central area 87 from collapsing in on port 51 of cover 52 andforming an unwanted seal which would effectively block air flow throughport 51 while suction is applied to bandage 11. Port 51 communicateswith the vacuum source 12 and/or the irrigation source 14 via connecter23 and tube 13, as shown in FIGS. 17-20. As mentioned above, port 51 isin communication with central area 87 of layer 80.

Illustratively, four bosses 90 are shown in FIG. 17. However, it iswithin the scope of this disclosure to provide any number of bosses 90,including eight bosses, or the like about central area 87 of layer 80 toprevent central area 87 from sealing off port 51 of cover 52 as suctionis applied to bandage 11. Further, it is within the scope of thisdisclosure to include bosses 90 having a tapered cross-section, as shownin FIG. 19, or to include a boss or bosses having any shape thatprevents central area 87 from sealing off port 51 when suction isapplied to bandage 11.

Alternative or supplemental bosses 91 are shown in FIG. 19. Bosses 91are positioned between bosses 90 and further prevent central area 87from collapsing on port 51 and forming an unwanted seal blocking airflow through port 51 while suction is applied to bandage 11. Alternativebosses 91 are generally rectangularly shaped and extend inwardly fromchannels 28 toward central area 87.

Connecter 23, as shown in FIGS. 17-19, is a tubal port coupled to a topsurface 53 of cover 52 and in communication with port 51 of cover 52. Asmentioned before, it is within the scope of this disclosure forconnecter 23 to be a separate component of member 19 which is coupled tocover 52 or for connecter 23 to be molded integrally with cover 52.Connecter 23 includes a passageway formed at a right-angle. Thus, thepassageway in connecter 23 has a vertical portion 25 that communicateswith port 51 and a horizontal portion 27 that communicates with verticalportion 25. Connecter 23 connects with tube 13 to provide a horizontaltube attachment with respect to port 51. A vertical tube attachment isshown in FIG. 32, for example. In FIG. 32, tube 13 is coupled directlyto port 51 of cover 52. Cover 52 includes a bottom surface 55 and topsurface 53, as shown in FIG. 17. Bottom surface 55 engages oppositesurface 85 of layer 80, as shown in FIGS. 18-20.

In some embodiments, member 19 is made by heat sealing opposite surface85 of layer 80 and bottom surface 55 of cover 52 together and by heatsealing connecter 23 to top surface 53 of cover 52. Member 20 of bandage10 may also be heat sealed to cover 52. With respect to member 19 ofbandage 11, for example, each of connecter 23, cover 52 (or thecombination of cover 52 and connecter 23), and layer 80 may bepre-shaped and formed from semi-cured silicone. Once the connecter 23,cover 52, and layer 80 are placed together appropriately, the entiremember 19 may be heated to heat seal and cure each of the threecomponents to one another. Alternatively, for example, the cover 52 onlymay be made from semi-cured silicone while the connecter 23 and layer 80may be made from fully cured silicone. Once placed together and heated,connecter 23 and layer 80 will heat seal to cover 52. Semi-cured siliconmay be bought and pre-molded from a manufacturer such as NuSilTechnology, for example. Although the method of heat sealing the cover52, connecter 23, and layer 80 to each other is disclosed, it is withinthe scope of this disclosure to form member 19 by coupling layer 80,cover 52, and port 51 together by any other means such as through theuse of adhesives, for example. Further, it is within the scope of thisdisclosure to provide a member 19 where cover 52 lies adjacent to, butis not coupled to, layer 80.

As mentioned above, cover 52 is coupled to layer 80 and connecter 23 iscoupled to cover 52 to form member 19. Cover 52 and layer 80 cooperateto form distinct passageways 56 of member 19 defined by channels 28, 30of layer 80 and bottom surface 55 of cover 52. Passageways 56 are incommunication with central area 87 of layer 80 and central area 87 oflayer 80 is in communication with port 51 of cover 52 which is incommunication with the vacuum and/or irrigation sources 12, 14 viaconnecter 23 and tube 13. Therefore, passageways 56 are in communicationwith the vacuum and/or irrigation sources 12, 14.

Layer 80 (similar to member 20) includes through holes 36 which extendfrom channels 28, 30 through layer 80 to wound contacting surface 84, asshown in FIGS. 18 and 19. Holes 36 are distinct and are provided tocommunicate with channels 28, 30 of layer 80. Holes 36 thereforecommunicate with passageways 56 of member 19 and the vacuum and/orirrigation sources 12, 14 as well to allow the suction from the vacuumsource 12 and/or the fluid from the irrigation source 14 to reach thewound surface 18 via the holes 36. As shown in FIGS. 2, 20, and 21,holes 36 have a staggered arrangement. Illustratively, holes 36 are0.030 inches (0.762 mm) in diameter and are spaced approximately 0.500inches (12.700 mm) apart along channels 28, 30 of layer 20. As mentionedbefore, however, it is within the scope of the disclosure to includeholes having other suitable sized diameters and/or other suitablespacing that allow for the removal of exudate without clogging. Forexample, the small and medium sized bandages, as described above, eachinclude holes having a diameter of 0.030 inches (0.762 mm) while thelarge sized bandage includes some holes having a diameter of 0.030inches (0.762 0101) and other holes having a diameter of 0.040 inches(1.016 mm). Bandage 11 further includes sealing layer or film 62 that isplaced over cover 52 and around tube 13, as shown in FIGS. 1 and 17 anddescribed above with respect to bandage 10. Film 62 may be substantiallylarger than the wound 16 or member 19 to provide an effective seal aboutthe member 19 and the wound 16. Bandage 11 does not include gauze orpacking 58 included in bandage 10.

Illustrative member 19 of bandage 11 includes a smooth wound contactingsurface 84, as shown in FIG. 17. Wound contacting surface 84 may also betextured or roughened as illustrated by irregular nubs 74 shown in FIGS.21 and 22. Nubs 74 may have different dimensions as shown by thickness,t1, and thickness, t2, in FIG. 22. By providing member 19 with atextured or roughened surface, a space is created between surface 84 oflayer 80 and wound surface 18. Through holes 36 communicate with thisspace which permits vacuum source 12 to establish a generally uniformlydistributed vacuum or negative pressure to the wound surface 18 to drawblood from the body to the wound surface 18 and to draw exudate from thewound 16 through holes 36, into channels 28, 30 and passageways 56, andout port 51 of cover 52. It is within the scope of this disclosure toinclude other means for providing a space between surface 84 and woundbed surface 18 such as providing ribs, protrusions, channels, spacers,etc, as described above with respect to member 20 of bandage 10.

The vacuum or negative pressure which draws blood from the body to thewound surface 18 and draws exudate from the wound 16 up through member19 promotes the healing of wound 16. As wound 16 heals, granulationsform along the wound surface 18. Granulations, therefore, are thereplacement within the wound bed of tissue lost. As the granulationsfill in the wound bed causing the wound 16 to heal, member 19 rides upon the wound surface 18 on top of the granulations which are formed.

Although illustrative bandage 10 includes one central port 40, it iswithin the scope of this disclosure to include multiple ports. It isfurther within the scope of this disclosure to provide an illustrativemember 619, as shown in FIGS. 35 and 36 and discussed below, havingmultiple ports and multiple passageway sets for use independent of eachother.

In order to accommodate different sized wounds 16, member 19 may betrimmed to fit a particular wound 16. As shown in FIG. 41, someembodiments of member 19 include scale markings 76, indicated by thedotted lines. Scale markings 76 indicate areas where a caregiver maytrim member 19 to fit a particular wound 16. Further, the scale markings76 may denote measurement sizes, for example, to permit a caregiver tocut the member 19 to fit a pre-measured wound 16. Also, as mentionedabove, the transparent nature of member 19 is illustrated in FIG. 41.

In order to accommodate various types and placements of wounds onpatients, member 19 may be provided in various conforming shapes andsizes. For example, illustrative embodiments of a member 119 are shownin FIGS. 23-25 for use with a wound on a patient's heel 117. Member 119is saddle-shaped and includes a top portion 150, a bottom portion 152,and a neck portion 154 integrally coupled to and spaced between topportion 150 and bottom portion 152, as shown in FIGS. 23 and 24. Member119 includes a right and a left side 156, 158 which are each shaped toform an inwardly facing “W”. Each W-shaped side 156, 158 includes a toppoint 160, a first trough 162, a peak 164, a second trough 166, and abottom point 168. The neck portion 154 is positioned between each of thepeaks 164.

Member 119 is similar to member 19 and includes a cover (not shown) anda wound contacting layer (not shown) having channels 28, 30 and throughholes 36. To form member 119, the cover and layer are each saddle-shapedand include matching W-shaped sides. The cover and layer cooperate toform passageways 56 of member 119 in a manner similar to the manner inwhich cover 52 and layer 80 (and cover 52 and member 20) cooperate toform passageways 56 in member 19. All similar features between member 19and alternate member 119 are marked with similar reference numerals. Thecover of member 119 includes port 51 formed in top surface 53 of thecover and in communication with connecter 23.

Port 51 and connecter 23 are centrally located and passageways 56radiate outwardly therefrom in the embodiment of FIG. 23.Illustratively, port 51 and connecter 23 are located on top portion 150of member 119, the embodiment shown in FIG. 24. Passageways 56 of member119 shown in FIG. 24 are defined by a central passageway 141 incommunication with port 51 of the cover and lateral passageways 142 incommunication with central passageway 141. The passageways 56 in theembodiment of FIG. 24 terminate before reaching the peripheral edge ofmember 119, whereas passageways 56 in the embodiment of FIG. 23 are openat the peripheral edge. As shown in FIG. 25, member 119 is folded to cupthe patent's heel 117. In the illustrative cupped configuration ofmember 119, troughs 162 of top portion 150 overlap troughs 166 of bottomportion 152.

A member 219 is illustratively shown in FIGS. 26 and 27 and is used totreat tunneled wounds such as wound 116. Member 219 includes a truncatedcone-shaped portion 250 and a tube-shaped portion 252 coupled tocone-shaped portion 250 at a first end 254. A dome-shaped tip 256 iscoupled to tube-shaped portion 252 at a second end 258 of thetube-shaped portion 252.

Member 219 is similar to members 119 and 19 in that member 219 includesa wound contacting layer 220 coupled to a cover 222. Further, woundcontacting layer 220 and cover 222 cooperate to form passageways 56which communicate with port 51 of cover 222 and connecter 23. Woundcontacting layer 220 is formed to define through holes 46 whichcommunicate with the passageways 56 of member 219 and with wound bedsurface 18 of tunneled wound 116.

Member 219 operates in the same or similar manner as members 119 and 19in that connecter 23 may be coupled to a vacuum source 12 forestablishing a vacuum about the wound bed surface 18 to draw blood up tothe wound bed surface 18 and/or to remove exudate from the wound bedsurface 18. Connecter 23 may also be coupled to irrigation source 14 tosupply fluids such as saline, for example, to the wound bed surface 18.As shown in FIGS. 26 and 27, port 51 and connecter 23 of member 219 arepositioned on the cone-shaped portion 250. However, it is within thedisclosure to position port 51 and connecter 23 anywhere on member 219.

Another illustrative member 319 is shown in FIGS. 28-30. Member 319 isprovided for use with abdominal or sternal wounds 316. FIG. 29 showsmember 319 being used to treat a sternal wound 316. As shown in FIGS. 29and 30, member 319 is generally “V-shaped” and includes a right wing 350and a left wing 352. Member 319 further includes a central portion 351having a central passageway 354 and a port 340 coupled to tube 41 forcommunication with either vacuum source 12 or irrigation source 14.Right and left wings 350, 352 are each coupled to central portion 351.Lateral passageways 356 are formed by the cooperation of a woundcontacting layer 320 and a cover 322 of member 319, as shown in FIG. 11.Lateral passageways 356 terminate before reaching the sides orperipheral edges of member 319. However, central passageway 354 is openat both a top and bottom edge of member 19. Through holes 36 are formedin wound contacting layer 320 and are provided for communication betweenpassageways 354 and the wound surface 18. Although the communicationbetween the wound surface 18 and the vacuum source 12 and/or irrigationsource 14 is provided through central and lateral passageways 354, 356,as shown in FIG. 28, it is within the scope of this disclosure toprovide a member 319 for use with abdominal and/or sternal wounds havinga different passageway structure for communicating the vacuum source 12with the wound surface 18. Further, although member 319 is V-shaped, itis within the scope of this disclosure to include a generally flatmember which is flexible to adjust to the contour of the sternal orabdominal wound to which it is applied.

Yet another illustrative embodiment is shown in FIG. 31 where agenerally dome-shaped member 419 is provided for use with deep woundshaving a wound surface including side walls, for example. Dome-shapedmember 419 is able to conform to side portions of a deeper wound bed,for example, to provide the side portions of the wound surface, as wellas the bottom portion of the wound surface with suction and irrigationtreatment. A port (not shown, but similar to port 51) is centrallylocated within member 419 and passageways 456 in communication withconnecter 23 extend radially therefrom, as shown in FIG. 31. Concentricpassageways 458 positioned around the port are also provided. Member 419includes a cover 422 and a wound contacting layer 420 including a convexwound contacting surface 84 and through holes 36 in communication withpassageways 456, 458. Wound contacting surface 84 is premolded to formthe convex shape.

As mentioned above and shown in FIGS. 17-22, member 19 includes a woundcontacting layer 80 and a cover 52 coupled to the wound contacting layer80 to form passageways 56. Passageways 56 are formed by the cooperationof layer 80 and cover 52. Specifically, passageways 56 are defined bythe channels 28, 30 of layer 80 and the bottom surface 55 of cover 52which covers and closes each channel 28, 30 to form passageways 56. Itis within the scope of this disclosure, however, to form passageways 56between a wound contacting layer 520 and a cover 522, as shown in FIG.33, for example. A member 519, as shown in FIGS. 33 and 34, includeswound contacting layer 520 and cover 522 coupled to wound contactinglayer 520. Connecter 23 is coupled to top surface 53 of cover 522 and isin communication with port 51 of cover 522. Cover 522 further includes aplurality of channels 530 radiating from port 51 and a plurality ofconcentric channels 531 formed around port 51. Further, cover 522includes bosses 90 coupled to bottom surface 55.

Wound contacting layer 520 includes through holes 36. Opposite surface85 of layer 520 is smooth such that passageways 562 are formed whenlayer 520 and cover 522 are coupled together. Effectively, member 19 andmember 519 each include a port 51 in communication with vacuum source 12and/or irrigation source 14, passageways 56 in communication with port51 and connecter 23, and holes 36 in communication with passageways 56and formed through wound contacting layers 80, 520. Member 19 and member519 each further include bosses 90 to prevent port 51 from becomingsealed off by central area 87 when suction is applied to bandage 11.Bosses 90 provide an uncollapsable space in central area 87 between port51 and passageways 56.

Members 19, 119, 219, 319, 419, and 519 discussed above areillustratively each provided for use with vacuum source 12 andirrigation source 14. As illustrated, these embodiments are providedwith one port 51 for communication with either the vacuum source 12 orthe irrigation source 14 or both. However, a member 616 is shown inFIGS. 35 and 36 and includes port 51, cover 52, layer 80 having a smoothor textured wound contacting surface 84, and an irrigation layer 650coupled to surface 84 of layer 80. Irrigation layer 650 includes anirrigation port 652 for communication with irrigation source 14, asshown diagrammatically in FIG. 36. Irrigation layer 650 includes anupper surface 654 and a lower surface 656. As shown in FIG. 36, lowersurface 656 is positioned to lie adjacent to the wound bed surface 18and upper surface 654 is coupled to surface 84 of layer 80. Asillustrated in this embodiment, layer 80 does not contact the wound bedsurface 18; layer 80 acts as an intermediate layer positioned betweencover 52 and irrigation layer 650. Irrigation layer 650 lies on thewound bed surface 18.

Further, irrigation layer 650 includes a plurality of channels 656formed in upper surface 654 in communication with irrigation port 652via a central channel 658 which is also formed in upper surface 654.Irrigation through holes 660 are formed in irrigation layer 650 and arepositioned to lie within channels 656 and central channel 658. Fluidfrom irrigation source 14 flows through irrigation port 652 to centralchannel 658 and lateral channels 656, and finally flows throughirrigation holes 660 to the wound bed surface 18, as shown in FIG. 36.Irrigation layer 650 further includes vacuum holes 662 positioned aroundchannels 656, 658. Vacuum holes 662 communicate with the wound bedsurface 18 and with through holes 36 of intermediate layer 80. Vacuumholes 662 do not directly communicate with channels 656, 658 ofirrigation layer 650. Irrigation layer 650 is illustratively made fromthe same material as cover 52 and intermediate layer 80 such assilicone, for example.

Cover 52 and layer 80 are the same cover and layer 22, 80 as those shownin FIG. 17 and discussed above. Connecter 23 coupled to cover 52 isprovided for communication with vacuum source 12. When cover 52,intermediate layer 80, and irrigation layer 650 are coupled together, asshown in FIG. 34, passageways 56 are formed between cover 52 andintermediate layer 80, as discussed above, and irrigation passageways664 are formed between surface 84 of layer 80 and upper surface 654 ofintermediate layer 650. Passageways 56 are in communication with vacuumsource 12 while passageways 664 are in communication with irrigationsource 14. As shown in FIG. 36, fluid flows into passageways 664 and outirrigation holes 660 to reach wound bed surface 18. This irrigationfluid and exudate from the wound surface 18 is then sucked up throughvacuum holes 662 of irrigation layer 650 and through holes 36 of layer80 to passageways 56 and finally out port 51 of cover 52. Member 619allows simultaneous delivery of irrigation fluid to the wound surface 18and application of suction to the wound bed surface 18 through separateand distinct passageways. Although the particular structure of member619 is shown in FIGS. 35 and 36 and discussed above, it is within thescope of this disclosure to include any member having separate anddistinct passageways for delivering fluid to and drawing a vacuum on thewound surface 18. It will be appreciated that, in some circumstances,the irrigation and suction may take place simultaneously.

Yet another illustrative member 719 is shown in FIGS. 37 and 38including a wound contacting layer 80 and a cover 52 coupled to thelayer 80. Member 719 further includes a filament or wire form 78 moldedinto the body of cover 52, as shown in FIG. 38, for example. Wire form78 is provided to allow for a caregiver to mold member 719 into adesired shape, such as to the shape of the wound 16, for example. Member719 will retain that shape due to the wire form 78 molded into the cover52. Illustrative wire form 78 is a metal grid, as shown in FIG. 37;however, it is within the scope of this disclosure to include any typeor configuration of a filament, fine screen, or wire form which retainsits shape once formed to fit a particular shape as desired by thecaregiver. Further, it is within the scope of this disclosure for thewire form 78 to be molded into either wound contacting layer 80 (ormember 20) or cover 52 or both. Further it is within the scope of thisdisclosure to include wire form 78 molded into the cover and/or woundirrigation layer of any of the previously disclosed embodiments.

Yet another illustrative member 819 is shown in FIGS. 39 and 40. A woundcontacting layer 820 includes an adhesive 850 about the outer perimeterof wound contacting surface 84 of layer 820. As shown in FIG. 40, cover52 is coupled to opposite surface 85 of layer 820 and connecter 23 iscoupled to top surface 53 of cover 52. Adhesive 850 is provided to sealto the patient's healthy skin 60 surrounding wound 16. Adhesive 850,therefore, permits member 819 to be self-sealing such that a vacuum ornegative pressure can be created above wound surface 18 without the useof sealing film 62. In order for adhesive 850 to be able to effectivelyseal to healthy skin 60, passageways 56 of member 819 are not formed toextend to the peripheral edges of member 819 unlike passageways 56 ofmember 19 which do extend to the peripheral edges of member 19. Althoughadhesive 850 is shown to be coupled to layer 820, it is within the scopeof this disclosure to provide any member having an adhesive forattachment to the patient's healthy skin surrounding the wound so thatthe member is self-sealing and able to maintain a negative pressureabove the wound without the use of a sealing film. For example, thewound contacting layer may be sized smaller than the cover and thebottom surface of the cover may include an outer adhesive perimeter forcoupling with the patient's surrounding healthy skin. Yet anotherillustrative member 919 is shown in FIGS. 42-44. Member 919 is similarto the other members disclosed above and includes a wound contactinglayer 920, cover 52 coupled to layer 920, and a connector 923 coupled tocover 52. As shown in FIGS. 42 and 44, connector 923 differs fromconnector 23 because connector 923 includes an outer wall 926 defining asingle passageway 928 to port 51 of cover 52. Outer wall 926 andpassageway 928 are positioned at an angle to top surface 53 of cover 52.In the illustrative embodiment, the included angle between an axisdefined by passageway 928 and the top surface of cover 52, when cover 52is in a flat configuration, is about 30 degrees.

It is understood that member 919 operates in the same or similar manneras the other members, such as members 19 and 20, described above. Assuch, the same reference numerals have been used to designate similarcomponents to those components previously discussed and additionaldiscussion thereof is not warranted.

One difference between member 919 and members 19 and 20 is that member919 includes a single stand-off 940, shown in FIG. 43, which generallyforms a spider-web-like pattern. Stand-off 940 is coupled to woundcontacting or wound facing surface 84 and includes interconnectingportions or ridges including radial arms 942, circle portion 944, andarc portions 946 concentric with circle portion 944. Specifically,stand-off 940 includes eight radial arms 942 extending outwardly fromcircle portion 944 and through arc portions 946. It is within the scopeof this disclosure, however, to include a stand-off having more circlesportions and/or arc portions interconnected by more or less radial arms.Further, it is within the scope of this disclosure to include astand-off forming other suitable interconnected patterns than that shownin FIG. 43. Although stand-off 940 includes radial arms 940, circleportion 944, and arc portions 946, the entire stand-off 940 is molded orformed as a single interconnected unit.

Stand-off 940 operates to position wound facing surface 84 of woundcontacting layer 920 away from wound surface 18 of wound 16 (shown inFIGS. 3, 7, and 17). By positioning wound facing surface 84 away fromwound surface 18, holes 36 (not visible in FIG. 42, but shown in FIGS.43 and 44) of layer 920 are less likely to form an unwanted seal againstwound surface 18. Stand-off 940 allows vacuum source 12 to establish agenerally uniformly distributed negative pressure to draw exudate fromthe wound 16 through holes 36 and into channels 28, 30, of layer 920.Stand-off 940 is not provided to direct fluid flow toward any singlehole 36, but instead, to prevent the holes 36 from becoming closed offand forming an unwanted seal against wound surface 18. As shown in FIG.43, for example, stand-off 940 forms either fully or partiallyclosed-off portions or encompassed regions of wound facing surface 84defined by circle portion 944, radial arm portions 942, and arc portions946. Each of the majority of the closed-off portions have multiple holes36 associated therewith. Thus, each closed-off portion has portions ofstand-off 940 fully or partially surrounding or encompassing associatedholes 36.

Illustratively, the radial arms 930 and arc portions 934 of stand-off940 extend to the outer peripheral edges of layer 920. It is within thescope of this disclosure, however, to include a stand-off having radialarms and/or arc portions which do not extend all the way to the outerperipheral edge of layer 920. Further illustratively, each radial arm930, each arc portion 934, and circle portion 932 has a semi-circleshaped cross-section having a radius of about 0.0625 inches (1.588 mm).

As mentioned above, another difference between member 919 and members 19and 20, for example, is that member 919 includes angled connector 923,as shown in FIGS. 42 and 44. Passageway 928 of connector 923 provides agenerally straight flow path for the exudate removed from wound 12through member 919 by vacuum source 12 and for the liquid delivered towound 12 through member 19 by irrigation source 14.

As shown in FIG. 44, a barbed tube coupler 950 is provided to coupleconnector 23 with a multi-lumen vacuum/irrigation tube 913.Illustratively, tube 913 includes an inner lumen 952 defined by an outerwall 954 of the tube 913. Tube 913 further includes outer lumens 956formed in outer wall 954. As shown in FIG. 44, inner lumen 952 is incommunication with passageway 928 of connector 923 via the tube coupler950 while outer lumens 956 are open to the area around member 919through an end edge 915 of tube 913.

Barbed tube coupler 950 is received within inner lumen 952 andpassageway 928. Coupler 950 includes a tube portion 960, a connectorportion 962, an intermediate portion 964 coupled to and positionedbetween tube portion 960 and connector portion 962, and a passageway 966through each of the tube portion 960, connector portion 962, andintermediate portion 964. Tube portion 960 is positioned within innerlumen 952 of tube 913 and includes a barb 970 to prevent tube portion960 from being easily removable from tube 913. Connector portion 962 ispress fit into connector 923 and includes an angled end 972 to generallyengage and lie adjacent to cover 52. Intermediate portion 964 ispositioned between and abuts each of the tube 913 and connector 923, asshown in FIG. 44. In some embodiments, adhesive or sealant is applied toeither or both of portions 960, 962 to further enhance the connectionbetween tube portion 960 of coupler 950 and tube 913 and betweenconnector portion 962 of coupler 950 and connector 923.

Although this invention has been described in detail with reference tocertain embodiments, variations and modifications exist within the scopeand spirit of the invention as described and defined in the followingclaims.

1. A wound dressing member for use in a vacuum bandage connected to avacuum source and for use with a wound having a wound surface, themember comprising: a wound facing surface adapted face toward the woundsurface, a plurality of discrete holes formed in the wound facingsurface, a port configured to communicate with the vacuum source andwith cacti hole, and a stand-off having interconnected portions coupledto the wound facing surface and configured to provide a space betweenthe wound facing surface and the wound surface.
 2. The member of claim1, wherein the stand-off includes a circle portion and a plurality ofradial arms extending outwardly from the circle portion.
 3. The memberof claim 2, wherein the stand-off includes at least one arc concentricwith the circle portion.
 4. The member of claim 1, wherein across-section of the stand-off is semi-circular in shape.
 5. The memberof claim 4, wherein the cross-section has a radius of approximately 1.56mm.
 6. The member of claim 1, further including encompassed regions ofthe wound facing surface separated from each other by portions of thestand-off.
 7. The member of claim 7, wherein the stand-off includes acircle portion, a plurality of radial arms extending outwardly from thecircle portion, and an arc portion concentric with the circle portion,and wherein at least one of the enclosed regions is defined between aportion of the circle, two adjacent radial arms, and the arc portion. 8.The member of claim 1, further including a connector coupled to a topsurface of the member, and wherein the connector is in communicationwith the port and configured to communicate with the vacuum source. 9.The member of claim 8, wherein the connector defines a single passagewaypositioned at an angle relative to the top surface of the member.
 10. Awound dressing member for use in a vacuum bandage connected to a vacuumsource and for use with a wound having a wound surface, comprising: awound facing surface configured to face toward the wound surface, and astand-off coupled to the wound facing surface and extending away fromthe wound facing surface, the stand-off forming an interconnectedpattern to define a plurality of encompassed regions of the wound facingsurface.
 11. The member of claim 10, wherein the stand-off forms aspider-web-like pattern.
 12. The member of claim 11, wherein thestand-off includes a circle portion and radial arms extending outwardlyfrom the circle portion.
 13. The member of claim 11, wherein thestand-off includes a semi-circular cross-section.
 14. The member ofclaim 10, wherein each encompassed region includes a plurality ofdiscrete holes formed through the wound facing surface and configured tocommunicate with the vacuum source and the wound surface.
 15. The memberof claim 14, wherein the member is made from a non-porous material. 16.The member of claim 10, further including a top surface and a connectorcoupled to the top surface and configured to couple with a tube incommunication with the vacuum source, and wherein the connector includesan outer wall defining a generally straight passageway therethrough. 17.The member of claim 16, wherein the passageway is positioned at an anglerelative to the top surface of the member.
 18. The member of claim 10,wherein some of the encompassed regions are tally encompassed by thestand-off and others of the encompassed regions are partiallyencompassed by the stand-off.
 19. A wound dressing member for use in avacuum bandage connected to a vacuum source and for use with a woundhaving a wound surface, the member comprising: a wound facing surfaceadapted face toward the wound surface, a plurality of discrete holesformed in the wound facing surface, a port configured to communicatewith the vacuum source and with each hole, and one or more ridgesprovided on the wound facing surface to form one or more encompassedregions in which one or more of the discrete holes are located.